Chargé de la Qualité et Conformité en alternance pour Economie d’Energie. Soutenir la conformité et le contrôle interne tout en participant à la transition énergétique en France.
About the role
- Senior Regulatory Affairs Manager ensuring compliance in clinical trials and market products for Amgen. Leading European regulatory strategies and submissions from clinical trials to marketing authorisation.
Responsibilities
- Work to ensure that Amgen acquires and maintains all the required licenses
- Advise the GRT on regional considerations in developing strategy
- Develop and execute regional regulatory product strategies
- Plan and manage regulatory submissions for products within Amgen's portfolio
- Implement product related regulatory strategies, Regulatory Affairs processes and activity planning
- Lead development of regional regulatory documents and meetings in accordance with GRT strategy
- Provide regulatory direction on regional regulatory mechanisms to optimize product development
- Advise on regulatory implications related to global clinical development plans and objectives
- Lead Health Authority and Agency Interactions and document and communicate outcomes appropriately
Requirements
- Degree educated in a scientific discipline
- Extensive experience in regional regulatory environment
- Proven track record of developing and executing regional regulatory strategy
- In-depth understanding of the drug life cycle and development process from a regulatory perspective
- In-depth understanding of the registration procedures in region for MA, post approval changes, extensions and renewals.
- Ability to lead teams and work collaboratively in a dynamic environment
- Proactive approach to problem solving
- Ability to understand and communicate scientific/clinical information
- Ability to anticipate regulatory agency expectations
- Strong awareness of the needs of internal and external stakeholders, and the role of Regulatory Affairs in driving successful drug development
Benefits
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
- Growth opportunities to learn and move up and across our global organization
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
Job title
Job type
Experience level
Salary
Not specified
Degree requirement
Location requirements
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